Phase I Study Compound 451238 and Radiotherapy in Soft-tissue Sarcoma

Summary

Participation Requirements

Description

Overall Study Design This is a single centre open label, non-randomized, non-placebo phase 1 clinical trial to establish the safety and tolerability compound 451238 in combination with radiotherapy in patients with soft tissue sarcomas (STS). STS patients receiving radiotherapy to a tumour deposit a...

Overall Study Design This is a single centre open label, non-randomized, non-placebo phase 1 clinical trial to establish the safety and tolerability compound 451238 in combination with radiotherapy in patients with soft tissue sarcomas (STS). STS patients receiving radiotherapy to a tumour deposit above the diaphragm in the thorax, trunk or extremity, will receive radiotherapy. This study will recruit 12 patients and run as a fixed dose trial. Patients will continue on the treatment regimen unless they progress, suffer unacceptable toxicities, or withdraw from the trial. Treatment Regimen A maximum of 12 patients will be recruited. The safety and tolerabilty will be assessed in the first 3+3 patients with expansion to 12 patients as tolerated. A minimum gap of 2 weeks will be left between treatment of the first and second patient (with the combination of RT) to mitigate against multiple patients suffering acute toxicity. Patients will be followed for a minimum of 11 weeks from the initiation of radiotherapy with combined compound 451238 for the purposes of acute toxicity monitoring. Late toxicity monitoring will commence from 11 weeks + one day from initiation of radiotherapy with combined compound 451238 and continue until disease progression or initiation of new anti-cancer therapy. Safety Follow-up - 30 Days All patients will be required to attend a safety follow-up visit 30 days after the last dose of compound 451238 or before the initiation of a new anti-cancer treatment, whichever comes first. Extended Safety Follow-up - 90 Days Given the potential risk for delayed toxicities, an extended safety follow-up visit must be performed up to 90 days after the last dose of compound 451238 administration. The extended safety follow-up will be performed either via a site visit or via a telephone call with subsequent site visit requested in case any concerns noted during the telephone call. All AEs and SAEs that occur prior to the safety follow-up visit should be reported as described in the trial protocol. After the safety follow-up any unresolved AEs at the patient's last visit should be followed up for as long as medically indicated, but without further recording in the CRF. Follow-up Patients who discontinue trial treatment for any reason other than disease progression will move into the follow-up phase and will be assessed every 12 weeks by MRI or radiologic imaging to monitor disease status. Every effort will be made to collect information regarding disease status until the start of new anti-cancer therapy, disease progression, death, withdrawal or end of the study. Information regarding post-study anticancer treatment will be collected if new treatment is initiated. Survival Follow-up Once a patient experiences confirmed PD or starts a new anti-cancer therapy, the patient moves into the survival follow-up phase and will be followed up every 12 weeks to determine their disease status. This will be done by reviewing their medical notes and/or contacting the patient and/or General Practitioner directly. Patients will remain on this follow-up until death, withdrawal of consent, or the end of the study, whichever occurs first.

Tracking Information